Caregivers Decision to Report Adverse Drug Reactions among Children Receiving Seasonal Malaria Chemoprevention in Ghana

IntroductionThe antimalarial medicines used in Seasonal Malaria Chemoprevention (SMC) campaigns are generally well-tolerated but adverse drug reactions (ADRs) can occur. Monitoring, reporting, and prompt management of ADRs is essential to build and maintain trust in SMC campaigns in the implementing communities. The caregivers decision to report ADRs represents a critical issue at the intersection of public health, child welfare, and pharmacovigilance. As SMC campaigns continue to expand, it is imperative to understand and address the factors influencing caregivers decisions to report ADRs. MethodsA mixed methods cross-sectional study involving questionnaire administration, focus group discussions, and review of childrens health records was employed to collect data from caregivers of children aged 3-59 months in the Northern, North-East, and Savanna regions of Ghana. A systematic random sample of 679 caregivers was recruited for the study across three regions. Data including ADR occurrence, maternal and child characteristics was collected from selected caregivers in their homes. Logistic regression was performed for associations between caregivers reports of ADRs and caregiver characteristics. ResultsAbout 49.5% (336/679) of caregivers mentioned the occurrence of ADRs in children after receiving SMC medication. The commonly cited ADR was diarrhea (34.7%, 116/336). Only 16.9% (57/336) of caregivers reported ADRs to the health workers at the time of occurrence. After adjusting for confounders, increasing age of child (aOR=1.04, 95%CI:1.008-1.065), receiving education on ADR reporting (aOR=4.03, 95%CI:4.366-6.119), education on management of mild ADRs (aOR=4.43, 95%CI:2.094-9.808) and having a means of reaching health personnel (aOR=1.56, 95%CI:1.202-2.037) increased the odds of ADR reporting while increasing age of caregivers (aOR=0.92, 95%CI:0.883-0.966) and being married (aOR=0.17, 95%CI:0.149-0.183) decreased the odds of reporting ADRs among the caregivers studied. ConclusionLess than 20% of caregivers whose children experienced ADRs after receiving SMC medication reported the incident. Caregiver education on ADRs and its management and means of reaching the health team were modifiable factors that influenced caregiver ADR reporting.